Ignite Creation Date:
2024-05-06 @ 7:16 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02501291
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2015-05-20
Brief Title:
Thalidomide in Treating Crohns Disease
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Thalidomide in Inducing and Maintaining Remission of Crohns Disease
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns disease CD is a chronic gastrointestinal inflammatory disease characterized by relapse and progression The incidence and prevalence of IBD are increasing in different regions around the world indicating its emergence as a global disease Though modern medical therapies including immunomodulators and biologic agents have revolutionized treatment of CD the occurrence of steroids-dependence and resistance or intolerance to medical therapy is quite common The limitation of present therapeutic management and the high expense of biologic agents leads to the treatment of CD become refractoriness The occurrence rate of steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during the course of CD Approximately 38 of cases required surgery within 10 years Therefore the management of such refractory CD remains a great therapeutic challenge for clinicians
Thalidomide is an oral agent that has immunomodulatory antiangiogenic and TNFtumor necrosis factor-a- suppressing effects The potential role for thalidomide in the treatment of refractory paediatric and adult CD has been investigated in more and more small open-label studies and retrospective case series Recently a randomized controlled trial showed thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in pediatric refractory CD Gerich et al reported in a retrospective study that thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a median of 58 months However the dose of thalidomide used in these studies ranged from 50mgd to 150mgd and the occurrence rate of side effects reported variously but all quite high The side effects related to the dose of thalidomide were the major concerns of using it in CD Moreover the effect of thalidomide on endoscopic response including mucosal healing which is a more objective and important outcome in CD was rarely reported Therefore the aim of this study is to investigate the efficacy on clinical and endoscopic response and the adverse effects of using low-dose thalidomide in active adult CD patients
Thalidomide is an oral agent that has immunomodulatory antiangiogenic and TNFtumor necrosis factor-a- suppressing effects The potential role for thalidomide in the treatment of refractory paediatric and adult CD has been investigated in more and more small open-label studies and retrospective case series Recently a randomized controlled trial showed thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in pediatric refractory CD Gerich et al reported in a retrospective study that thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a median of 58 months However the dose of thalidomide used in these studies ranged from 50mgd to 150mgd and the occurrence rate of side effects reported variously but all quite high The side effects related to the dose of thalidomide were the major concerns of using it in CD Moreover the effect of thalidomide on endoscopic response including mucosal healing which is a more objective and important outcome in CD was rarely reported Therefore the aim of this study is to investigate the efficacy on clinical and endoscopic response and the adverse effects of using low-dose thalidomide in active adult CD patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None